[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1150]

[Page 362-363]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                             Subpart B_Drugs
 
Sec.  73.1150  Dihydroxyacetone.

    (a) Identity. (1) The color additive dihydroxyacetone is 1,3-
dihydroxy-2-propanone.
    (2) Color additive mixtures for drug use made with dihydroxyacetone 
may contain only those diluents that are listed in this subpart as safe 
and suitable in color additive mixtures for coloring externally applied 
drugs.
    (b) Specifications. Dihydroxyacetone shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Volatile matter (at 34.6 [deg]C. for 3 hours at a pressure of not more 
than 30 mm. mercury), not more than 0.5 percent.
Residue on ignition, not more than 0.4 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Iron (as Fe), not more than 25 parts per million.
1,3-dihydroxy-2-propanone, not less than 98 percent.

    (c) Uses and restrictions. Dihydroxyacetone may be safely used in 
amounts consistent with good manufacturing practice in externally 
applied

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drugs intended solely or in part to impart a color to the human body. 
Authorization for this use shall not be construed as waiving any of the 
requirements of section 505 of the act with respect to the drug in which 
it is used.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.